1. Field of the Invention
This invention relates to the field of sterile disposal of device such as catheters, and the like used for injecting or withdrawing fluids into or from the body and, in particular, to a sheath disposed around such a device which may be drawn up to enclose the used device and tied off for sterile disposal thereof.
2. Description of the Prior Art
Catheters and other devices for use in draining off accumulated fluids from body cavities or injecting fluids into the body have been widely used in many medical fields for a long period of time. With reference to catheters, there are numerous types and designs, any of which are particularly adapted to be inserted into a particular body cavity. For example, an urethral catheter is designed to drain urine from the bladder. A ventricular catheter is adapted to drain excess cerebrospinal fluid from the brain. A peritoneal catheter is used to drain fluid from the peritoneum, as in kidney dialysis. An enema catheter is used to introduce fluid into the gastrointestinal track.
All of the above-mentioned types of catheters, as well as others too numerous to enumerate, have certain design features in common. A typical medicinal catheter is formed of hollow, flexible tubing. The tubing is typically comprised of a silicone elastomer such as silicone rubber, a substance which is soft and non-irritating to body tissues. A typical catheter will have a closed end and an open end. One or more inlets will be formed adjacent the closed end. An outlet will be formed adjacent the open end, and frequently will be comprised of the open end itself. Catheters designed for different purposes may additionally comprise other structures, but the ones enumerated are generally common to all catheters. Also, the dimensions of the catheter may vary greatly and will be adapted to the purpose for which it is intended. For example, a catheter adapted as an urinary catheter may typically have an outside diameter in the range of 0.3-0.8 millimeters. In contrast, a ventricular catheter will have a much smaller diameter.
No matter the particular type, most catheters are used in a similar manner. The closed end of the catheter carrying the outlets is inserted into the body cavity containing the fluid which needs to be drained inserted. The insertions process may be directly through a body orifice, such as is the usual case with urethral catheters, or a special opening may have to be made. For example, an opening may have to be made into a vein and the catheter threaded through the vein until it reaches the appropriate body cavity, such as is the case with ventricular catheters. After the catheter is inserted, some means of collecting the fluid must be attached to the open, outlet end. Sometimes, as for ventricular catheters, the outlet end of the catheter will remain within the body and the excess fluid drained will be absorbed by another area of the body. More commonly, however, the excess fluid will simply be collected in a bag or bottle and discarded. The catheter may be left in place for long periods of time, or the excess body fluid may be drained quickly and the catheter removed after only a short period of insertion.
Irrespective of what type of catheter is used, how long it remains in place, or what type of body fluid it is used to drain, all catheters must eventually be disposed of. When the catheter is no longer needed, it will be removed from the body and then must be disposed. If the catheter has been used with a patient suffering from a communicable or infectious disease, the catheter so used will be highly likely to be contaminated with an infectious agent. If such contaminated catheters are simply discarded in a casual manner, the possibility of contaminating attendant personnel and perhaps other patients is high.
The same disposal problem arises with other medical devices that come in contact with body fluids. For example, syringes are commonly used to inject or withdraw fluids from, for example, the circulatory system, the lymphatic system, the cerebrospinal system, etc. Most commonly, the syringes are disposable and used only once. Since they must be disposed of after each use, the possibility of contamination from a used syringe is quiet significant.
The problem of disposal of contaminated catheters and other devices is particularly acute in the management of patients afflicted with such highly infectious diseases as acquired immune deficiency syndrome (AIDS). For diseases such as AIDS, where the exact mechanism of transmission is poorly understood, it is extremely important that attending personnel be isolated as much as possible from all potential sources of infection. Even more significantly, the apprehension by persons attending AIDS patients that they may be contaminated with the disease by the mere handling of objects used in the treatment of the patients, such as used catheters or syringes, may interfere with the ability of the attending personnel to provide proper care and treatment of the patient.
Heretofore, the only solution to the problem of sanitary disposal of catheters and other devices used in the treatment of highly infectious patients have been ad hoc, unsatisfactory ones. For example, a used catheter may be removed from the patient and immediately placed within a sterile container, such as a plastic bag, the container then being sealed. However, due to the shape of the catheter and the flexible, resilient material from which it is typically made, it is difficult to place the unwieldy catheter within the container without having to attempt to fold it or roll it up. Obviously, the motions involved in doing this caused such unnecessary and dangerous handling of the contaminated catheter.
It would be desirable to provide a means for sterile containment and subsequent disposal of a device such as a catheter which has been in contact with body fluids which minimizes handling of the contaminated object.
It would also be desirable to provide a means of disposal which is mounted directly around the device and eliminates the necessity of a separate container.
It would also be desirable to provide a device and mounted means of disposal which could easily enclose and contain the used device by a simple, one-step unrolling motion.
It would also be highly desirable to provide a device mounted disposal means which is easy to use and has the additional advantages of being cheap to manufacture and sterilize.